1. Field of the Invention
The present invention relates to systems and methods for cardiopulmonary bypass, and in particular the present invention relates to a novel system and method of mechanical heart-lung substitution which is fully portable and semi-automatic and which is particularly adapted for utilization outside the hospital environment as an emergency life-support system for sustaining the life of a patient suffering from acute, severe, lift-threatening cardiac and/or respiratory failure.
2. The Prior Art
When acute, severe, life-threatening but potentially reversible interruption of natural cardiac and/or pulmonary function occurs, emergency application of effective methods for maintaining at least partial cardiopulmonary function until the primary threat to life can be corrected may permit all vital organs and/or systems to resume normal self-regulating function, thereby averting death. In actual clinical practice, such life-support efforts currently take one of three forms: (1) emergency cardiopulmonary resuscitation (CPR); (2) temporary mechanical cardiopulmonary bypass (CPB) for support of patients undergoing open heart surgery; and (3) modified partial cardiopulmonary bypass, which is also called extracorporeal membrane oxygenation (ECMO), which is used for mechanical assistance of patients in acute, severe but reversible pulmonary failure.
CPR is used each day to save literally several hundred persons who collapse unexpectedly at home, at work, in the field, or in hospitals, and is an accepted technique for providing temporary cardiopulmonary assistance in emergency situations. However, there is no question that cardiopulmonary bypass machines or extracorporeal membrane oxygenation systems are much more effective in maintaining proper hemodynamic function and blood gas exchanges than is cardiopulmonary resuscitation. In proper hospital environments, cardiopulmonary bypass and/or extracorporeal membrane oxygenation can be carried out longer and with much higher survival rates than can be achieved with cardiopulmonary resuscitation.
Unfortunately, notwithstanding the substantial advantages that can be derived from using cardiopulmonary bypass and/or extracorporeal membrane oxygenation systems, such systems are not currently available outside the operating room or hospital environment, and they require considerable preparation time before they can be applied. For example, typical cardiopulmonary bypass machines are relatively large in size and are highly complicated, usually requiring the use of skilled perfusionists in order to run them. Patients who undergo cardiopulmonary bypass also require major thoracic surgery and therefore the presence of a skilled surgeon is needed in typical situations. Moreover, proper management of the usual cardiopulmonary bypass machine requires the use of highly technical invasive monitoring systems to monitor and record the vital signs of the patient. Thus, for obvious reasons, these types of cardiopulmonary bypass and/or extracorporeal membrane oxygenation systems are not available or practical for use outside the setting of a rather sophisticated hospital facility.
It would be a substantial advance in the state of the art to provide a fully portable mechanical heart-lung substitution system which could be used without the need for major surgical operation and which would be semi-automatic so as to simplify the ease of using and the reliability of such a system. Such an invention would have an important impact on the ability of paramedics or other emergency personnel to provide adequate, temporary cardiopulmonary life support while transporting a patient to a fully equipped hospital facility for longer term or more definitive care. Such an invention is disclosed and claimed herein.